NCT06535997

Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE

Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE - PRIMHADRON

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Since the 1990s, carbonetherapy radiotherapy has been developed in a few sites around the world, mainly to treat inoperable and highly radioresistant tumors. In the absence of a treatment center of this type in France, the French health insurance system and health authorities (DGOS, INCa and HAS) have contributed to the setting up of a prospective randomized controlled study, PHRC-ETOILE, to evaluate this practice, and have also authorized, on the basis of expert opinion, treatment outside the PHRC of patients who could not be included in the PHRC but whose indications were very similar to those mentioned in the PHRC. This "out-of-study" cohort began in October 2010, and has continued to grow steadily. By the end of 2022, it had reached 53 patients. It is important to study the impact of carbonetherapy on these patients, in order to gain an initial appreciation of the benefits, tolerability and contribution of this practice for patients. Local control, progression-free survival and overall survival in this cohort will be studied, as well as the role of carbon therapy in the management of these patients, some of whom are very complex. Complications attributable to carbon therapy, care pathways and changes in patients' quality of life will also be analyzed. This analysis will make a contribution to the overall evaluation of carbonetherapy, assessing its usefulness and therefore the benefit to patients of its application. In our future prospects, some of these cases (around 23) could be used to consolidate the PHRC-ETOILE cohort. This study will contribute to the development of the case for carbonetherapy, enabling the health authorities to make an informed decision on whether or not to expand access to this therapy. * PHRC-ETOILE (First Transnational Randomized Prospective Trial Comparing Carbon Therapy versus Non-Carbon Therapy for Radioresistant Tumors) * PHRC (Hospital clinical research programme)

Conditions

• Cancer
• Cystic Carcinomas, Adenoid
• Soft-tissue Sarcomas
• Rhabdomyosarcoma Pleomorphic
• Sarcoma,Soft Tissue
• Osteosarcomas
• Chondrosarcoma, Grade 3
• Chordoma
• Angiosarcomas

Interventions

Type	Name	Description
OTHER	Questionnaire	For patients alive only at the time of inclusion, completion of a quality-of-life questionnaire and a medico-economic interview (prospective).

Timeline

• Start date: 2025-05-23
• Primary completion: 2025-07-14
• Completion: 2025-07-14
• First posted: 2024-08-02
• Last updated: 2025-08-06

Locations

2 sites across 1 country: France